Zanubrutinib, Obinutuzumab Combined With Lenalidomide (ZGR) for the Treatment of Untreated Follicular Lymphoma

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-90
SponsorInstitute of Hematology & Blood Diseases Hospital, China

About this trial

This study is planned to prospectively evaluates the efficacy and safety of the zanubrutinib, obinutuzumab, and lenalidomide (ZGR) combination regimen in treatment-naïve follicular lymphoma (FL) patients in a Chinese population.

Eligibility criteria

Qualifiers

Gender: No restrictions; age ≥18 years.

Diagnosis: Histologically confirmed CD20-positive follicular lymphoma (FL), Grade 1, 2, or 3A, per 2016 WHO classification. All patients must provide sufficient archived or fresh tumor tissue samples for immunohistochemical (IHC) analysis.

a) Bulky disease: Lymph node or extranodal (excluding spleen) mass with maximum diameter ≥7 cm.

b) Local symptoms or organ dysfunction due to progressive lymphadenopathy or extranodal tumor mass.

Disqualifiers

Histologic evidence of central nervous system (CNS) lymphoma, leptomeningeal lymphoma, or transformation to high-grade lymphoma (e.g., diffuse large B-cell lymphoma, DLBCL).

Grade 3B follicular lymphoma (FL) or transformed FL.

Ann Arbor Stage I FL.

Prior history of malignancy, unless the patient has been disease-free for ≥5 years and the treating physician deems the risk of recurrence low (exceptions: non-melanoma skin cancer, cured localized prostate cancer, carcinoma in situ of the cervix, or squamous intraepithelial lesions on PAP smear).

Trial design

Treatments tested in this trial

  • Induction Therapy: Zanubrutinib, obinutuzumab, lenalidomide
  • Maintenance therapy: Zanubrutinib, lenalidomide

Treatment groups

34 Participants
are divided into 1 treatment group